Navigation Links
HIV/AIDS Research Network Recommends Use of Abbott RealTime Viral Load Test for NIH-Sponsored Clinical Trials

ABBOTT PARK, Ill., May 7 /PRNewswire-FirstCall/ -- The Abbott RealTime HIV-1 Assay and Abbott m2000 System have been recommended as a standard protocol for viral load testing in HIV/AIDS clinical trials sponsored by the National Institutes of Health (NIH).

This recommendation was made by the Cross-Network Laboratory Focus Group (LFG), which consists of representatives from five of the NIH-sponsored HIV/AIDS clinical trials networks. The LFG recently issued a consensus statement, which was reviewed and approved by the leadership of the five networks, recommending the use of the Abbott RealTime HIV-1 assay and m2000 system for upcoming clinical trials in 2009 and beyond that have a primary focus on viral load measurements. The recommendation applies to testing performed at adult and pediatric therapeutic HIV/AIDS clinical trial sites both in the United States and internationally, as well as the centralized network laboratories in the United States.

Viral load testing is a monitoring tool used to determine the amount of virus in the blood and the efficacy of anti-HIV therapy. The growing prevalence of HIV-1 subtype variant and circulating recombinant strains has made accurate viral load detection more complex and has prompted increasing numbers of clinical laboratories to adopt the Abbott RealTime HIV-1 Assay on the m2000 System. The system is one of the fastest and most sensitive viral load tests available, with the ability to detect and precisely measure group M, N and O strains of HIV-1, as well as all known non-B subtypes.

"We're pleased that the LFG has recommended the Abbott RealTime HIV viral load assay to be the standard testing system for NIH-sponsored HIV/AIDS clinical trial networks," said Stafford O'Kelly, head of Abbott's molecular diagnostics business. "We look forward to supporting the NIH-sponsored clinical trials networks in the global effort to evaluate and monitor HIV drug treatments."

Based on several published studies, current molecular or PCR based diagnostic tests vary in their ability to detect and reliably quantify variant strains of HIV-1 and have been found to under-quantify them. "The performance and precision of the Abbott RealTime HIV-1 assay for detecting variant subtypes allows physicians to confidently measure viral levels and provide optimal drug treatment," O'Kelly said.

The NIH-sponsored networks include the: AIDS Clinical Trials Group, International Maternal Pediatric Adolescent AIDS Clinical Trials Group, HIV Prevention Trials Network, HIV Vaccine Trials Network, and Microbicide Trials Network. The networks are an affiliated group of national and international medical research institutions and investigators that conduct clinical HIV/AIDS research to develop safe and effective drugs, prevention strategies and HIV vaccines.

About the Abbott RealTime HIV-1 Test

The Abbott RealTime HIV-1 assay is among the most sensitive viral load tests available today. The test has demonstrated the ability to detect diverse group M subtypes of HIV (including all known non-B subtypes) as well as group N and O isolates.

The Abbott RealTime HIV-1 test is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis and for use as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels. The assay is not intended to be used as a donor-screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection.

About the Abbott m2000 Instrument System

The Abbott RealTime HIV-1 test runs on the Abbott m2000, an automated system that uses real-time polymerase chain reaction (PCR) to amplify, detect and measure minute levels of virus in blood samples as well as extremely high levels of these infectious agents. Real-time PCR enables the production of large quantities of DNA from very small samples in a short period of time, making it possible to detect extremely low levels of a virus's genetic material. The Abbott m2000 system automates the important steps of the process, from sample preparation to data analysis, allowing laboratories to process molecular tests efficiently, accurately and confidently.

In addition to having a best-in-class assay for HIV-1, Abbott's m2000 system is faster than competitive systems, delivering 96 test results in less than six hours for HIV-1 as compared to up to two days for other systems.

About Abbott

Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 72,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available at the company's Web site at

Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. GeoVax Starts Injections for Phase 2a Human HIV/AIDS Vaccine Trial in USA
2. GeoVaxs Phase 2a HIV/AIDS Vaccine Human Trials to Begin in North and South America
3. German Innovation for HIV/AIDS Diagnostics has Been Used 2.5 Million Times in 2008
4. Inverness Medical Innovations Participates in Meeting on HIV/AIDS with UN Secretary-General
5. Research Attributes Lack of HIV/AIDS Vaccine to Use of Chimpanzees
6. Successful Results for Mymetics Corporations Mucosal HIV/AIDS Vaccine Viral Challenge Significantly Exceeds Expectations
7. NCPS Outraged at HIV/AIDS Medi-Cal Cuts
8. Landmark HIV/AIDS Publication Launches at International AIDS Society Conference in Mexico City
9. Test for Life Campaign Screens Record Number of DC Residents for HIV/AIDS
10. U.S. Patent Office Rejects Key HIV/AIDS Drug Patents at PUBPAT Request: Government Finds Prior Art Submitted By PUBPAT Invalidates All of Gilead Sciences Claims
11. On World AIDS Day, CHF International Calls for Community Mobilization and Local Capacity Building to Fight HIV/AIDS
Post Your Comments:
(Date:11/25/2015)... , Nov. 25, 2015 ... the addition of the "Global Brain ... their offering. --> ) ... "Global Brain Monitoring Devices Market 2015-2019" ... Research and Markets ( ) has ...
(Date:11/25/2015)... THOUSAND OAKS, Calif. , Nov. 25, 2015 /PRNewswire/ ... of a Biologics License Application (BLA) with ... Administration (FDA) for ABP 501, a biosimilar candidate to ... the first adalimumab biosimilar application submitted to the FDA ... biosimilar pathway. Sean E. Harper , M.D., ...
(Date:11/25/2015)... WOODBURY, N.Y. , Nov. 25, 2015  Linden ... access and optimizing treatment outcomes for patients suffering from ... its request for a Temporary Restraining Order (TRO) enjoining ... between the two companies. --> ... aggressively pursuing all of its legal options. ...
Breaking Medicine Technology:
(Date:11/28/2015)... ... November 28, 2015 , ... Safe storage for contraceptive ... two inventors, one from Lakewood, New Jersey and the other from Bradley Beach, New ... PROTECTOR to save the expense of having to replace NuvaRings more often than necessary. ...
(Date:11/27/2015)... Canada (PRWEB) , ... November 28, 2015 , ... There ... do we outperform our billings from last year? , This question has not been ... organizations are coming to the retirement age and the younger workforce don’t share the ...
(Date:11/27/2015)... ... November 27, 2015 , ... The rapid speed at which ... age, more care is needed, especially with Alzheimer’s, dementia and other cognitive conditions ... overworked. The forgotten part of this equation: 80 percent of medical care occurs ...
(Date:11/27/2015)... ... 27, 2015 , ... Lizzie’s Lice Pickers just announced a special promotion that ... of their purchase of lice treatment product. In addition, customers will receive a complimentary ... spokesperson. “Finding lice is a sure way to ruin the holidays, so we encourage ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... through sharing, the 2016 Building Better Radiology Marketing Programs meeting will ... on Sunday, March 6, 2016, at Caesars Palace in Las Vegas with a ...
Breaking Medicine News(10 mins):